UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Comparative Review of Airwayscope and Styletscope in case of CVCI
Title of the study (Brief title)	A Comparative Review of Intubation devices in case of CSM
Region	Japan

Condition
Condition	cervical spondylotic myelopathy
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the usefulness of the stylet scope
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The intubation time, and Change of vital signs, especially blood pressure, heart rate,and SpO2
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	We use an air way scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.
Interventions/Control_2	We use a stylet scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	94 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who receive a diagnosis of the cervical spondylotic myelopathy, and undergo cervical vertebrae laminoplasty
Key exclusion criteria	The patients who requried Subconscious fiber intubation, that an agreement was not obtained beforehand, are stage of more than ASA3
Target sample size	100

Research contact person
Name of lead principal investigator	HIRANO HIROKO
Organization	CHUBU ROSAI Hospital
Division name	Anesthesiology
Address	1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture
TEL	052-652-5511
Email	hrk0203ykng@gmail.com

Public contact
Name of contact person	HIRANO HIROKO
Organization	CHUBU ROSAI Hospital
Division name	Anesthesiology
Address	1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture
TEL	052-652-5511
Homepage URL
Email	hrk0203ykng@gmail.com

Sponsor
Institute	Anesthesiology of CHUBU ROSAI Hospital
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 03 Day
Last modified on	2017 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022955